Diabetes Technology & Therapeutics
ISSN / EISSN: 15209156 / 15578593
Published by: Mary Ann Liebert Inc
Total articles ≅ 3,184
Latest articles in this journal
Diabetes Technology & Therapeutics; https://doi.org/10.1089/dia.2022.0452
Objective: Nationwide reimbursement of intermittently-scanned continuous glucose monitoring (isCGM) was introduced in Belgium (2016). This real-world observational study investigates the impact of isCGM over 24 months on adults with type 1 diabetes with impaired or normal awareness of hypoglycemia (IAH or NAH). Methods: We included 1905 people who started first-generation 14-day FreeStyle Libre (without alerts). Sixteen percent had IAH. Primary endpoint was evolution of quality of life (QOL); secondary endpoints were evolution of severe hypoglycemia, work absenteeism, HbA1c, and sensor-measured outcomes. Results: At baseline, people with IAH (n=308) had significantly worse QOL than people with NAH (n=1594). Only people with IAH improved on the hypoglycemia fear survey-worry subscale after 24 months (22.8 [95%CI 21.4-24.2] baseline; 20.6 [19.0-22.1] 24 months, p=0.002). For both groups, Diabetes Treatment Satisfaction Scale improved over 24 months (IAH: +3.1 [2.1-4.1],p<0.001; NAH: +2.3 [1.9-2.7], p<0.001), while general QOL, diabetes distress, and HbA1c remained stable. People with IAH showed the strongest decline in work absenteeism and severe hypoglycemia (36.4% having an event six months prior to isCGM-initiation; 16.0% having an event during last six months of follow-up, p<0.001), with similar observations for hypoglycemia hospitalization, and hypoglycemia coma. Over 24 months, people with IAH spent more time in hypoglycemia, but less time in hyperglycemia than people with NAH. Conclusion: This data show sustained improvement of severe hypoglycemia, work absenteeism and hypoglycemia fear after isCGM-reimbursement, mostly driven by people with IAH. Together with improved treatment satisfaction, irrespective of hypoglycemia awareness level, isCGM without alerts is a valuable tool under long-term real-world conditions.
Diabetes Technology & Therapeutics; https://doi.org/10.1089/dia.2023.0054
Diabetes Technology & Therapeutics; https://doi.org/10.1089/dia.2022.0540
Automated insulin delivery (AID) systems have established benefits in terms of glycemic control, health outcomes, and quality of life and are strongly recommended for people with type 1 diabetes outside of pregnancy. While evidence for use of investigational AID systems during pregnancy is promising, data and guidance are still needed regarding use of commercially-available systems during pregnancy. Unfortunately, none of the hybrid closed-loop (HCL) systems that are currently available in the U.S. have glucose targets which are as aggressive as pregnancy glycemic targets, none have a pregnancy-specific algorithm, and none are approved for use during pregnancy. As such, any use of these systems during pregnancy is considered off-label in the U.S. and would be “assisted” by provider/user techniques. Despite these limitations, many women conceive while using clinically-available HCL systems and may be hesitant to cease use during pregnancy. Achievement of strict pregnancy glycemic targets can be difficult, and it is conceivable that selective off-label use of clinically-available HCL systems in some women could lead to improved glycemia. We herein offer expert guidance based on clinical experience and available case reports on how to identify appropriate candidates for HCL therapy in pregnancy, how to counsel pregnant women with diabetes on the potential risks and benefits of HCL therapy during pregnancy, and how to manage commercially-available systems off-label throughout gestation in an assisted HCL approach.
Diabetes Technology & Therapeutics; https://doi.org/10.1089/dia.2022.0498
Objective: To explore clinical consequences and potential root causes of insulin pump-associated adverse events (AEs) reported in the Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database. Research Design and Methods: Qualitative template analysis of narrative data in a 20% stratified random sample (n = 2,429) of reported AEs that occurred during the first six months of 2020 involving five insulin pump models marketed at that time: (1) MiniMed 670G, (2) MiniMed 630G, (3) Omnipod, (4) Omnipod DASH, and (5) t:slim X2. Results: Of the 2,429 AEs, 92% included a clinical consequence in the narrative description, with critical hyperglycemia (i.e., blood glucose (BG) greater than 400 mg/dL; 47%) and critical hypoglycemia (i.e., BG less than 54 mg/dL; 24%) being the most common consequence cited. Only 50% of the AE narratives included information to support the identification of a root cause. The most cited root cause informing remarks were issues with the pump or pod reservoir/cartridge (9%), the occurrence of an obstruction of flow alarm (8%), and problems with the infusion set or site (8%). Some clinical consequences and root cause informing remarks were cited more frequently in AE narratives involving specific insulin pump models, but manufacturer variability in the amount and type of information reported may have affected these findings. Conclusions: Our findings show general themes found in insulin pump-associated AE that providers can use to raise patient awareness of potential risks associated with insulin pump use and develop strategies to prevent future AEs. Improvements in AE investigation and reporting processes are still necessary.
Diabetes Technology & Therapeutics; https://doi.org/10.1089/dia.2022.0542
In an in-patient switch study, 10 adults with type 1 diabetes (T1D) performed 45-minutes of moderate intensity exercise on two occasions : 1) when using their usual insulin pump (UP) and 2) after transitioning to automated insulin delivery (AID) treatment (MiniMedTM 780G). Consensus glucose management guidelines for performing exercise were applied. Plasma glucose (PG) concentrations measured over a 3-hour monitoring period were stratified into time spent below (TBR [10.0 mmol/L]) target range. Overall, TBR (UP: 11±21 vs. AID: 3±10 %, p=0.413), TIR (UP: 53±27 vs. AID: 66±39 %, p=0.320) and TAR (UP: 37±34 vs. AID: 31±41 %, p=0.604) were similar between arms. A proportionately low number of people experienced exercise-induced hypoglycaemia (UP: n=2 vs. AID: n=1, p=1.00). In conclusion, switching to AID therapy did not alter patterns of glycaemia around sustained moderate intensity exercise in adults with T1D.
Diabetes Technology & Therapeutics; https://doi.org/10.1089/dia.2022.0449
Aim To analyse evaluate the efficacy, safety and satisfaction of the closed-loop system Accu-Chek Insight with Diabeloop™ (DBLG1) in adults with type 1 diabetes (T1D) in real-world conditions. Methods Patients with T1D using DBLG1 for at least 3 months were included. Glucometric parameters were analysed at baseline, 1, 2 and 3 months after starting DBLG1. HbA1c was measured before and at 3 months. Technical issues and acute complications were recorded and patients completed a satisfaction questionnaire. Results Sixty-two patients were included (43 women; age 44.2±11 years; diabetes duration 24.6±12 years; 40 used flash and 22 continuous glucose monitoring; 45 were on insulin pump therapy, 17 on multiple daily injections). A significant improvement was observed in all the CGM-derived glucose metrics eparameters early in the first month: %TIR (55.86±17 vs. 72.23±10.11); %TAR1 (26,26±13.3 vs. 19.48±6.78), %TAR2 (15.02±13.09 vs. 6.14±5.23), %TBR1 (5.73±11.5 vs. 1.67±1,3), %TBR2 (1,18±1.97 vs.0.44±0.49), %CV (38.66±7.53 vs. 29.63±3.74), median glucose (168.57 mg/dl±36 vs. 154.63±17.55), %GMI (7.37±0.91 vs. 7.02±0.42). HbA1c decreased significantly at 3 months (7.45%±1.05 vs. 6.95±0.7). No acute complications or serious adverse events occurred. The sameSimilar improvement was observed regardless of prior therapy or glucose monitoring system used. Three patients stopped discontinued use of using DBLG1 and 21 experienced some technical problemsissues. Overall, patientThe degree of satisfaction was high in most of the questions raised. Adjustments of the settingsThe configuration parameters were modified in general in the direction of greater aggressiveness. Conclusions A significant improvement in glycaemic control without serious adverse events and high degree of patient satisfaction was observed in this first real-world study evaluating the close-loop system Accu-Chek Insight with Diabeloop™
Diabetes Technology & Therapeutics, Volume 25, pp 97-99; https://doi.org/10.1089/dia.2023.0004
Diabetes Technology & Therapeutics, Volume 25, pp 100-107; https://doi.org/10.1089/dia.2022.0313
Objective The safety and impact of the advanced hybrid closed-loop (AHCL) system on glycemic outcome in 2–6-year-old children with type 1 diabetes and the diabetes distress of caregivers were evaluated. Research Design and Methods This was an open-label prospective study (n=35) with historical controls matched by treatment unit, diabetes duration, age, gender, and baseline treatment modality. The inclusion criteria were 1) type 1 diabetes diagnosis > 6 months, 2) total daily dose of insulin ≥ 8 units/day, 3) HbA1c < 10% (85 mmol/mol), and 4) capability to use insulin pump and continuous glucose monitoring (CGM). The MiniMed 780G™ AHCL in SmartGuard™ Mode was used for 12 weeks. Parental diabetes distress was evaluated with a validated PAID-PR (Problem Areas In Diabetes – Parent, revised) survey. Results No events of diabetic ketoacidosis (DKA) or severe hypoglycemia occurred. Between 0 and 12 weeks, Hba1c (mean change= -2.7 mmol/mol [SD 5.7], p=0.010), mean sensor glucose value (SG) (-0.8 mmol/l [1.0], p<0.001), and time above range (TAR) (-8.6% [9.5], p<0.001) decreased and time in range (TIR) (8.3% [9.3], p<0.001) increased significantly, whereas no significant change in time below range (TBR) was observed. At the same time, PAID-PR score decreased from 37.5 (18.2) to 27.5 (14.8) (p=0.006). Conclusions MiniMed 780G™ AHCL is a safe system and 12-week use was associated with improvements in glycaemic control in 2–6-year-old children with type 1 diabetes. Additionally, AHCL is associated with a reduction in parental diabetes distress after 12-week use.
Diabetes Technology & Therapeutics, Volume 25, pp 116-121; https://doi.org/10.1089/dia.2022.0246
Background: Malglycemia in pediatric, adolescent and young adult (AYA) patients who undergo hematopoietic stem cell transplant (HSCT) is associated with increased infection and mortality. Continuous glucose monitoring (CGM) has been safely used in pediatric/AYA HSCT recipients, but there is a need for a composite metric that can easily be used in clinical settings to assess the glycemic control and identify high-risk patients who needs therapeutic intervention. Composite metrics derived from CGM have not been studied in pediatric/AYA HSCT patients. Method: Patients aged 2-30 years old who are admitted inpatient while undergoing HSCT at Children’s Hospital Colorado underwent CGM using the Abbot Freestyle Libre Pro device from up to 7 days before and 60 days after HSCT. A composite metric Q-score, comprised of five primary factors of CGM profiles (central tendency, hyperglycemia, hypoglycemia, intra-daily and inter-daily variations), was calculated for each patient for the duration of CGM wear. Results: Twenty-nine patients received CGM for an average of 25 days per participant. The median Q-score was 10.2 (IQR: 8.3, 14.3). 69% of patients had Q-scores that would be categorized into the Fair or Poor category. There was no difference in the Q-score by sources of stem cell, types of primary disease, types of preparative regimen, need for PICU admission, presence of documented infections, and total parenteral nutrition (TPN) use in the peri-HSCT period. Conclusions: Most pediatric/AYA HSCT recipients have Q-scores indicating suboptimal glycemic control in peri-HSCT period. Future study should focus on developing screening and treatment strategies to improve malglycemia and its associated adverse clinical outcomes.
Diabetes Technology & Therapeutics, Volume 25, pp 131-139; https://doi.org/10.1089/dia.2022.0340
Objective: To evaluate changes in insulin pump use over two decades in a national U.S. sample. Research Design and Methods: We used data from the SEARCH for Diabetes in Youth study to perform a serial cross-sectional analysis to evaluate changes in insulin pump use in participants <20 years old with type 1 diabetes by race/ethnicity and markers of socioeconomic status across four time periods between 2001 and 2019. Multivariable generalized estimating equations were used to assess insulin pump use. Temporal changes by subgroup were assessed through interactions. Results: Insulin pump use increased from 31.7% to 58.8%, but the disparities seen in pump use persisted and were unchanged across subgroups over time. Odds ratio for insulin pump use in Hispanic (0.57, confidence interval [95% CI] 0.45–0.73), Black (0.28, 95% CI 0.22–0.37), and Other race (0.49, 95% CI 0.32–0.76) participants were significantly lower than White participants. Those with ≤high school degree (0.39, 95% CI 0.31–0.47) and some college (0.68, 95% CI 0.58–0.79) had lower use compared to those with ≥bachelor's degree. Those with public insurance (0.84, 95% CI 0.70–1.00) had lower use than those with private insurance. Those with an annual household income <$25K (0.43, 95% CI 0.35–0.53), $25K–$49K (0.52, 95% CI 0.43–0.63), and $50K–$74K (0.79, 95% CI 0.66–0.94) had lower use compared to those with income ≥$75,000. Conclusion: Over the past two decades, there was no improvement in the racial, ethnic, and socioeconomic inequities in insulin pump use, despite an overall increase in use. Studies that evaluate barriers or test interventions to improve technology access are needed to address these persistent inequities.